ASCO GU 2021:ERLEADA联合ZYTIGA治疗转移性去势抵抗性前列腺癌III期临床

2021-02-09 Allan MedSci原创

与对照组相比,联合组患者的中位rPFS延长了6个月(22.6 vs. 16.6个月,危险比 0.69,95%CI 0.58-0.83,p<0.0001)。

强生制药公司今天公布了一项随机、双盲、安慰剂对照的III期临床(ACIS研究)的结果,该研究达到了放射学无进展生存期(rPFS)的主要终点,将初治转移性去势抵抗性前列腺癌(mCRPC)患者的死亡风险降低了31%。该试验的患者接受了ERLEADA®/ZYTIGA®/泼尼松(联合用药组)的治疗,或安慰剂/ZYTIGA®/泼尼松(对照组)的治疗。结果将在美国临床肿瘤学会泌尿学会(ASCO GU)研讨会上公布。

初步疗效分析显示,与对照组相比,联合组患者的中位rPFS延长了6个月(22.6 vs. 16.6个月,危险比 0.69,95%CI 0.58-0.83,p<0.0001)。根据中位随访54.8个月的最新分析,与对照组相比,联合组的影像学进展或死亡风险降低了30%。对于次要终点,包括总生存期(OS)、开始细胞毒性化疗的时间等,两组没有统计学上的显著差异。

纪念斯隆·凯特琳癌症中心的Dana Rathkopf博士说:“ACIS研究的数据表明,在评估ERLEADA联合ZYTIGA联合泼尼松治疗转移性去势抵抗性前列腺癌的治疗中,rPFS的显著提高”。

 

原始出处:

https://www.firstwordpharma.com/node/1798228?tsid=28&region_id=5

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    2021-10-01 juliusluan78
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createdName=yige2012, createdTime=Mon Nov 01 09:08:54 CST 2021, time=2021-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916404, encodeId=0c2f1916404c6, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Fri Oct 01 21:08:54 CST 2021, time=2021-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653159, encodeId=4d0616531591f, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri May 14 08:08:54 CST 2021, time=2021-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264765, encodeId=9ea91264e65bb, content=<a href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342157, encodeId=6823134215e5e, content=<a href='/topic/show?id=da143e23485' target=_blank style='color:#2F92EE;'>#去势抵抗性前列腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37234, encryptionId=da143e23485, topicName=去势抵抗性前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353199, encodeId=efd0135319937, content=<a href='/topic/show?id=a872695382' target=_blank style='color:#2F92EE;'>#Erleada#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6953, encryptionId=a872695382, topicName=Erleada)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386708, encodeId=49631386e08a5, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466232, encodeId=f66f146623252, content=<a href='/topic/show?id=56fb19113a3' target=_blank style='color:#2F92EE;'>#Zytiga#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19113, encryptionId=56fb19113a3, topicName=Zytiga)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82186780852, createdName=lqrandywkz, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503962, encodeId=3ab615039625f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1939132, encodeId=eabd19391324c, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Mon Apr 19 22:08:54 CST 2021, time=2021-04-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1666068, encodeId=a1fa166606896, content=<a href='/topic/show?id=6f7d553159c' target=_blank style='color:#2F92EE;'>#抗性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55315, encryptionId=6f7d553159c, topicName=抗性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4d5926034382, createdName=yige2012, createdTime=Mon Nov 01 09:08:54 CST 2021, time=2021-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916404, encodeId=0c2f1916404c6, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Fri Oct 01 21:08:54 CST 2021, time=2021-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653159, encodeId=4d0616531591f, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri May 14 08:08:54 CST 2021, time=2021-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264765, encodeId=9ea91264e65bb, content=<a href='/topic/show?id=150f19229c' target=_blank style='color:#2F92EE;'>#ADA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1922, encryptionId=150f19229c, topicName=ADA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342157, encodeId=6823134215e5e, content=<a href='/topic/show?id=da143e23485' target=_blank style='color:#2F92EE;'>#去势抵抗性前列腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37234, encryptionId=da143e23485, topicName=去势抵抗性前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353199, encodeId=efd0135319937, content=<a href='/topic/show?id=a872695382' target=_blank style='color:#2F92EE;'>#Erleada#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6953, encryptionId=a872695382, topicName=Erleada)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386708, encodeId=49631386e08a5, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1466232, encodeId=f66f146623252, content=<a href='/topic/show?id=56fb19113a3' target=_blank style='color:#2F92EE;'>#Zytiga#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19113, encryptionId=56fb19113a3, topicName=Zytiga)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82186780852, createdName=lqrandywkz, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503962, encodeId=3ab615039625f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Thu Feb 11 01:08:54 CST 2021, time=2021-02-11, status=1, ipAttribution=)]
    2021-02-11 柳叶一刀
  6. [GetPortalCommentsPageByObjectIdResponse(id=1939132, encodeId=eabd19391324c, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Mon Apr 19 22:08:54 CST 2021, time=2021-04-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1666068, encodeId=a1fa166606896, content=<a href='/topic/show?id=6f7d553159c' target=_blank style='color:#2F92EE;'>#抗性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55315, encryptionId=6f7d553159c, topicName=抗性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4d5926034382, 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  7. 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    2021-02-11 zhaojie88
  8. 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    2021-02-11 lqrandywkz
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杨森前列腺癌新药获FDA扩大适应症批准

强生集团旗下杨森(Janssen)公司近日宣布,FDA已批准了ZYTIGA(醋酸阿比特龙)联合泼尼松(prednisone)治疗转移高危性去势敏感型前列腺癌(CSPC)患者。该批准基于关键3期临床试验LATITUDE的数据。研究发现,在转移高危性CSPC患者中与安慰剂相比,ZYTIGA联合泼尼松将死亡风险降低了38%。

欧盟委员会(EC)扩展了Zytiga的许可证,以治疗早期前列腺癌

Janssen-Cilag International NV(Janssen)宣布,欧盟委员会(EC)已批准扩大Zytiga(醋酸阿比特龙)联合泼尼松/泼尼松龙的现有上市许可,目前的适应症扩大到早期转移性前列腺癌。醋酸阿比特龙联合泼尼松/泼尼松龙现在可以联合雄激素剥夺疗法(ADT)治疗成年男性新诊断的高危转移性激素敏感性前列腺癌(mHSPC)。"前列腺癌是整个欧洲男性最常见的癌症形式,该决定有助于

Onvansertib能够克服Zytiga耐药性并为mCRPC患者提供临床益处

Trovagene是一家临床阶段的肿瘤治疗公司,其研究性新药Onvansertib预期用于治疗包括前列腺癌、结肠直肠癌和白血病在内的多种癌症,该公司近日宣布,正在进行的Onvansertib与Zytiga联合治疗转移性去势抵抗性前列腺癌(mCRPC)的II期试验取得了积极结果。

Trovagene在ASCO-GU会议上介绍了Onvansertib与Zytiga联合治疗mCRPC的II期研究

Trovagene是一家临床阶段肿瘤治疗公司,采用精准医学方法开发白血病、淋巴瘤和实体瘤癌症的治疗药物,Trovagene近日在加利福尼亚州旧金山的Genitourinary Cancer Symposium(ASCO-GU)会议上公布了正在进行的第II阶段研究,该研究评估了Onvansertib与Zytiga(醋酸阿比特龙)联合治疗转移性去势抵抗性前列腺癌(mCRPC)患者的安全性和耐受性。

重磅!强生Zytiga霸主地位不保,安斯泰来前列腺癌药物Xtandi拿下欧美2大市场

安斯泰来(Astellas)和Medivation合作研发的新一代前列腺癌口服药物Xtandi(enzalutamide)监管方面爆出大好消息。继今年9月FDA批准Xtandi用于前列腺癌化疗前治疗,近日欧盟也已批准Xtandi用于化疗前治疗。尽管强生(JNJ)新一代前列腺癌口服药物Zytiga早在2011年4月上市之后一直统治市场,但Xtandi具有单独用药的独特优势,业界预测,在欧美2大主要市

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Cancer Immunol | 帕博利珠单抗与镭-223联合治疗转移性去势抵抗性前列腺癌的随机II期研究

该研究旨在评估镭-223联合帕博利珠单抗治疗转移性去势抵抗性前列腺癌患者的疗效,镭-223联合帕博利珠单抗治疗转移性去势抵抗性前列腺癌患者,相较于单独使用镭-223,并没有显示出显著的生存期改善。

Nat. Commun:双极雄激素疗法加纳武利尤单抗治疗转移性去势抵抗性前列腺癌患者:COMBAT Ⅱ期试验

该研究旨在探索BAT与纳武利尤单抗联合用于mCRPC患者的安全性和疗效,与单用BAT相比,纳武利尤单抗的加入可能改善了临床结局。

【专家访谈】如何看待FDA批准他拉唑帕利联合恩扎卢胺治疗HRR突变的mCRPC?

研究人员发现,与恩扎卢胺单药相比,他拉唑帕利联合恩扎卢胺使疾病进展或死亡风险降低了 55% ,这令我印象深刻。尽管OS(总生存期)数据尚不成熟,但OS获益呈积极趋势。

Lancet Oncol:奥拉帕利联合阿比特龙与安慰剂联合阿比特龙治疗转移性去势抵抗性前列腺癌(PROpel):一项随机、双盲、3期试验的最终预先指定的总生存结果

该研究旨在报告了PROpel研究的最终预先指定的总生存期和安全性分析结果,研究结果显示治疗组之间的总生存期没有统计学意义上的显著差异,安全性与初步分析一致。

病例分析8|转移性去势抵抗性前列腺癌全覆盖放疗

一例伴有腹膜后淋巴结转移的转移性去势抵抗性前列腺癌 (mCRPC)患者,多线药物治疗后进展,行转移淋巴结全覆盖放疗后,PSA降至测不出水平,已持续两年。

Clin Cancer Res:奥拉帕尼在ctDNA BRCA/ATM变异的转移性去势抵抗性前列腺癌中疗效

当肿瘤组织检测不可行或失败时,ctDNA检测可能是鉴别可能受益于奥拉帕尼治疗的携带BRCA/ATM变异的mCRPC患者的合适选择